This invention relates to improvements in instruments of the general type described in U.S. Pat. Nos. 4,963,814; 4,999,582; 4,999,632; 5,288,636; 5,366,609; and, 5,508,171. It is disclosed in the context of such instruments. However, it is believed to be useful in other applications as well.
Hand held instruments for the determination of physical and biological parameters such as, for example, the concentrations of medically significant components, such as glucose, of biological fluids, such as blood, are in widespread use. Such instruments permit people to monitor such characteristics and treat themselves or take other appropriate action to halt or reverse undesirable trends in the concentrations of such components. In diabetics, for example, such corrective action might be something as simple as intake of a particular type of food, for example, fruit juice, or an injection of insulin. In persons who are monitoring a clotting characteristic of their blood, such corrective action might be, for example, taking of a blood thinner or clotting factor.
An electrical apparatus for use with an electrical cell for providing power includes a first connector for contacting one of the terminals of the cell and a second connector for contacting the other of the terminals of the cell when the cell is installed in the apparatus. The second connector includes a base portion fixed in the apparatus, a first leg portion resiliently connected to and extending away from the base portion, a second leg portion resiliently connected to and extending away from the first leg portion, and a third leg portion resiliently connected to and extending away from the second leg portion and toward the first leg portion. Installation of the cell in the apparatus causes the other terminal to resiliently engage the second leg portion.
Illustratively according to this aspect of the invention, the second leg portion also extends away from the base portion.
Further illustratively according to this aspect of the invention, the third leg portion has an extension that extends away from the base portion.
Additionally illustratively according to this aspect of the invention, the electrical apparatus comprises an instrument for determining the concentration of a medically significant component of a biological sample.
Illustratively according to this aspect of the invention, the electrical cell comprises a dry cell. The installation of the dry cell into the apparatus causes the one terminal to engage the first connector.
Further illustratively according to this aspect of the invention, the electrical apparatus includes a well for receiving the cell. The well includes an opening through which the first connector is exposed to the well, and a boss adjacent the opening. The boss precludes the other terminal from engaging the first connector when the cell is inserted into the well in incorrect orientation.
Additionally illustratively according to this aspect of the invention, the electrical apparatus includes a circuit board to which the base portion of the second connector is fixed.
Illustratively according to this aspect of the invention, the first leg portion of the second connector extends away from the base portion at an angle between about five degrees and about ten degrees with respect to a line perpendicular to the base portion and generally in a first direction. The second leg portion extends away from the first leg portion at an angle between about fifteen degrees and about twenty five degrees with respect to the perpendicular line and generally in a second direction opposite to the first direction. The third leg portion extends toward the base portion at an angle of between about forty degrees and about fifty degrees with respect to the perpendicular line and generally in the first direction.
Further illustratively according to this aspect of the invention, the second connector comprises BeCu 190 alloy.
Additionally according to this aspect of the invention, the second connector comprises a 60/40 tin/lead plating.
Illustratively according to this aspect of the invention, the radii of curvature of the portions of the second connector between the base portion and the first leg portion, the first leg portion and the second leg portion, and the second leg portion and the third leg portion are substantially constant.
Further illustratively according to this aspect of the invention, the third leg portion has an extension that extends away from the base portion, and the radius of curvature of the portion of the second connector between the extension and the third leg portion is also substantially constant.
According to another aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological sample includes a display for displaying an operational status thereof, the display having a lens consisting essentially of a substantially transparent substrate with a polyurethane coating.
Illustratively according to this aspect of the invention, the substantially transparent substrate is constructed from polycarbonate resin.
According to another aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological sample comprises a housing having first and second portions, at least one locator pin extending from one of the housing portions and at least one complementary socket extending from the other of the housing portions for receiving the pin to maintain the first and second portions in assembled orientation.
Illustratively according to this aspect of the invention, the locator pin and the complementary socket have substantially circular cross sections perpendicular to their longitudinal extents.
Further illustratively according to this aspect of the invention, the engaging surfaces of the locator pin and the complementary socket are provided with complementary drafts to provide sufficient frictional engagement to hold the first and second portions together when they are assembled.
Additionally illustratively according to this aspect of the invention, the apparatus includes at least two locator pins and two complementary sockets.
Illustratively according to this aspect of the invention, both of the locator pins are disposed on the first housing portion and both of the complementary sockets are disposed on the second housing portion such that the locator pins are received in the respective ones of the complementary sockets when the first and second housing portions are assembled together.
According to another aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological sample includes first and second keys for use in operating the apparatus. The keys extend from a common support mounted in the apparatus. Each of the keys has a reduced cross sectional portion adjacent to the common support to promote substantially independent activation of the first and second keys.
Illustratively according to this aspect of the invention, the apparatus comprises a third key disposed between the first and second keys for use in operating the apparatus. The third key also has a reduced cross sectional portion adjacent to a second support mounted in the apparatus.
Further illustratively according to this aspect of the invention, the common support has a relief portion for receiving the second support such that the three keys generally define a surface when the apparatus is assembled.
Additionally illustratively according to this aspect of the invention, the apparatus includes a housing having first and second portions. The apparatus includes a circuit mounted to one of the housing portions and having a set of three terminals. The apparatus further includes means for securing the keys when the first and second housing portions are assembled together such that the keys, when activated, operate respective ones of the terminals.
Illustratively according to this aspect of the invention, the apparatus includes a compressible member disposed between the keys and the terminals of the circuit.
Further illustratively according to this aspect of the invention, the compressible member comprises a resilient pad dimensioned to isolate the terminals physically to reduce the possibility of contaminants interfering with the operation of the instrument.
Additionally illustratively according to this aspect of the invention, the means for securing the keys comprises pins extending from the other housing portion for reception in a corresponding plurality of openings disposed in the key supports to capture the supports between the other housing portion and the circuit.
According to another aspect of the invention, an apparatus for determining the concentration of a medically significant component of a biological sample comprises a strip and an instrument. The instrument comprises a slot through which the strip is intended to be inserted. The strip has at least one electrical contact thereon in communication with the sample. The instrument includes an electrical connector for engagement with the electrical contact of the strip when the strip is inserted into the instrument for determining the concentration. The instrument includes first and second housing portions. The slot is provided in one of the housing portions and the connector is mounted in the other of the housing portions. The other housing portion includes a member fixed thereto to engage the connector resiliently when the housing portions are assembled together to promote alignment of the connector with the slot.
Illustratively according to this aspect of the invention, the apparatus includes a circuit board mounted in the other housing portion. The electrical connector is disposed on the circuit board.
Further illustratively according to this aspect of the invention, the slot has a rib portion for guiding the strip when the strip is inserted into the instrument to promote engagement of the electrical contact of the strip with the electrical connector of the instrument.
Additionally illustratively according to this aspect of the invention, the resilient engagement of the member with the connector promotes alignment of the connector with the slot generally in a first direction. The rib portions guides the strip in a second direction generally perpendicular to the first direction.
Illustratively according to this aspect of the invention, the apparatus includes a second member fixed to the other housing portion for resiliently engaging the connector when the housing portions are assembled together to promote alignment of the connector with the slot in cooperation with the first-mentioned member.
According to another aspect of the invention, a method is provided for operating an instrument. The instrument includes a housing for at least some of the instrument components. The instrument components housed within the housing have at least first and second operating states. The instrument components evolve heat at a first time rate when the instrument is in the first operating state and at a second time rate when the instrument is in the second operating state. The instrument components include a controller. The controller keeps a record of how long the instrument is operated in each of said first and second states and calculates from the record the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states.
Illustratively according to this aspect of the invention, the instrument components housed within the instrument include a device for producing an output indicative of temperature. The method further comprises the step of adjusting the indicated temperature based upon the calculated heating of the interior of the housing.
Further illustratively according to this aspect of the invention, the step of adjusting the indicated temperature based upon the calculated heating of the interior of the housing comprises the step of subtracting the calculated heating of the interior of the housing from the indicated temperature.
Additionally illustratively according to this aspect of the invention, the instrument comprises an instrument for determining the concentration of a medically significant component of a sample. The method further comprises providing a strip, dosing the strip with the sample, providing on the instrument a port for receiving the strip, inserting the dosed strip into the port, determining an ambient temperature within the housing, adjusting the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, and determining the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.
Illustratively according to this aspect of the invention, the strip contains a chemistry for reacting with the medically significant component of the sample and producing across two terminals of the strip a signal indicative of the reaction. Dosing of the strip followed by receiving the strip in the port enables the determination of the first concentration.
Further illustratively according to this aspect of the invention, the medically significant component is glucose and the chemistry reacts with glucose to produce at least one of a voltage and a current indicative of the glucose concentration of the sample across the terminals of the strip.
According to another aspect of the invention, an instrument includes a housing for at least some of the instrument components. The instrument components housed within the housing have at least first and second operating states. The instrument components evolve heat at a first time rate when the instrument is in the first operating state and at a second time rate when the instrument is in the second operating state. The instrument components include a controller for keeping a record of how long the instrument is operated in each of said first and second states and calculating from the record the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states.
Illustratively according to this aspect of the invention, the instrument components housed within the instrument include a device for producing an output indicative of temperature. The controller is coupled to the device for producing an output indicative of temperature for adjusting the indicated temperature based upon the calculated heating of the interior of the housing.
Further illustratively according to this aspect of the invention, the controller is coupled to the device for producing an output indicative of temperature for subtracting the calculated heating of the interior of the housing from the indicated temperature.
Additionally illustratively according to this aspect of the invention, the instrument comprises an instrument for determining the concentration of a medically significant component of a sample. The apparatus further comprises a strip for dosing with the sample. The instrument includes a port for receiving the strip. The controller adjusts the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states. The instrument determines the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.
Illustratively according to this aspect of the invention, the strip contains a chemistry for reacting with the medically significant component of the sample and at least two strip terminals. The port includes at least two complementary instrument terminals. The strip terminals make contact with respective instrument terminals when the strip is inserted into the port. The chemistry reacts with the medically significant component of the sample to produce across at least two of the strip terminals a signal indicative of the reaction. Receiving the strip in the port and dosing of the strip enables the determination of the first concentration.
Further illustratively according to this aspect of the invention, the medically significant component is glucose and the chemistry reacts with glucose to produce at least one of a voltage and a current indicative of the glucose concentration of the sample across the strip terminals.
According to another aspect of the invention, an instrument for determining the concentration of a medically significant component of a sample includes a controller and a power supply for providing power to the controller. The power supply includes an inductance, a first solid state switch in circuit with the inductance, a first rectifier and a first capacitance in a second circuit for rectifying and storing the voltage variations appearing across one of the first switch and inductance. The controller provides a first switching signal for the first switch.
Illustratively according to this aspect of the invention, the apparatus further comprises a second rectifier and a second capacitance in a third circuit for rectifying and storing the voltage variations appearing across one of the first switch and inductance. The second circuit stores voltage variations of a first polarity appearing across one of the first switch and inductance and the third circuit stores voltage variations of a second and opposite polarity appearing across one of the first switch and inductance.
Further illustratively according to this aspect of the invention, the apparatus further comprises a transistor-transistor logic-to-RS-232 (TTL-to-RS-232) interface. The TTL-to-RS-232 interface is coupled across the second circuit and the third circuit.
Additionally illustratively according to this aspect of the invention, the apparatus further comprises a third rectifier and a third capacitance. The second and third rectifiers and the second and third capacitances are in a fourth circuit configured as a voltage multiplier.
Illustratively according to this aspect of the invention, the apparatus further comprises a second switch in circuit with the first capacitance. The controller further provides a second switching signal for the second switch.
Further illustratively according to this aspect of the invention, the second switch comprises a second solid state device for regulating the voltage across the first capacitance when the second switch is in a first state. The second solid state device halts regulation of the voltage across the first capacitance when the second switch is in a second state.
Additionally illustratively according to this aspect of the invention,the first switching signal is pulsewidth modulated.
According to another aspect of the invention, an instrument for determining the concentration of a medically significant component of a sample includes a controller and a display for displaying at least one of test status and results of tests to determine the concentration of the medically significant component of a sample. The controller is coupled to the display to display a first group of multiple results having a common characteristic simultaneously.
Illustratively according to this aspect of the invention, the common characteristic is that the multiple results of the first group were taken within twenty-four hours of each other.
Further illustratively according to this aspect of the invention, the results of the first group are displayed chronologically.
Additionally according to this aspect of the invention, the controller further controls the display to display a second group of multiple results taken within the same twenty-four hours as are the results of the first group.
Illustratively according to this aspect of the invention, the results of the first group are displayed chronologically whenever they are displayed and the results of the second group are displayed chronologically whenever they are displayed.
Further illustratively according to this aspect of the invention, the results of the first group and, where present, the second group, are assignable to respective time intervals within the same twenty-four hour period, which time intervals are user-selectable.
Additionally illustratively according to this aspect of the invention, the instrument further comprises a key for permitting the user to select to have the results of the first group or the results of the second group displayed at a given time.
According to another aspect of the invention, an instrument for determining the concentration of a medically significant component of a sample includes at least one key for the entry of information by a user, a controller for assigning to the at least one key a function selected from a group of at least two functions, and a display for displaying for the user an assignment by the controller of the function to the at least one key.
Illustratively according to this aspect of the invention, the apparatus further comprises a strip for dosing with the sample. The instrument includes a port for receiving the strip to enable the instrument to determine the concentration of the medically significant component of the sample.
Further illustratively according to this aspect of the invention, the strip contains a chemistry for reacting with the medically significant component of the sample and a pair of strip terminals. The port includes a complementary pair of instrument terminals. The strip terminals make contact with respective instrument terminals when the strip is inserted into the port. The chemistry reacts with the medically significant component of the sample to produce across the pair of strip terminals a signal indicative of the reaction. Receiving the strip in the port and dosing of the strip enables the determination of the first concentration.
Additionally illustratively according to this aspect of the invention, the medically significant component is glucose and the chemistry reacts with glucose to produce at least one of a voltage and a current indicative of the glucose concentration of the sample across the pair of strip terminals.
Illustratively according to this aspect of the invention, the instrument comprises a hand held instrument for determining the glucose concentration of the sample.
Further illustratively according to this aspect of the invention, the strip contains a chemistry for reacting with the medically significant component of the sample. The port includes a device for assessing the reaction of the chemistry with the medically significant component of the sample and for producing a signal indicative of the assessment. Dosing of the strip and receiving the strip in the port enables the determination of the concentration.
According to another aspect of the invention, an instrument for determining the concentration of a medically significant component of a sample includes a controller, at least one key for the entry of information by a user, and a display for displaying results of tests to determine the concentration of the medically significant component of a sample. The controller is coupled to the at least one key and to the display to permit the user to enter into the controller a first range of values for the concentration of the medically significant component of the sample. The display displays the first range. The controller produces an indication during a subsequent determination of the concentration whether the subsequently determined concentration falls within the first range.
Illustratively according to this aspect of the invention, the instrument comprises a hand held instrument for determining the glucose concentration of the sample.
Further illustratively according to this aspect of the invention, the apparatus further comprises a strip for dosing with the sample. The instrument includes a port for receiving the strip to enable the instrument to determine the concentration of the medically significant component of the sample.
Additionally illustratively according to this aspect of the invention, the medically significant component is glucose and the chemistry reacts with glucose to produce an indication of the glucose concentration of the sample.
Illustratively according to this aspect of the invention, the controller further permits the user to enter into the controller a second range of values for the concentration of the medically significant component of the sample. The display displays the second range. The controller produces an indication during a subsequent determination of the concentration whether the subsequently determined concentration falls within the second range.